510(k) · Cleared

Cleared

Interlink System-T-Connector Extension Set, Model 2N3326

K060074510(k) TraditionalCleared Mar 29, 200678-day reviewClass II21 CFR 880.5440

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Baxter Healthcare Corp · FPA Set, Administration, Intravascular

Cleared on Mar 29, 2006 as substantially equivalent to K921899 (Baxter Healthcare Corp, 1993) after a 78-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.

Decided: Mar 29, 2006
Review: 78 days
Class: Class II
Product code: FPA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K921899 (1993). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK921899 Interlink System - T-Connector Extension SetBaxter Healthcare Corp · 1993 · Recalled
This deviceK060074 Interlink System-T-Connector Extension Set, Model 2N3326Baxter Healthcare Corp · 2006
Descendant · cites it directly · 0 of its ownK112799 Med-RX Extension Set with T-ConnectorBenlan, Inc. · 2011

Most influential descendants

Showing 1 of 1 · See all

K112799Med-RX Extension Set with T-ConnectorBenlan, Inc. · 2011 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K921899	Interlink System - T-Connector Extension Set	Baxter Healthcare Corp	1993	8
0 (this device)	K060074	Interlink System-T-Connector Extension Set, Model 2N3326	Baxter Healthcare Corp	2006	—
+1	K112799	Med-RX Extension Set with T-Connector	Benlan, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0

FIG. 1 — Lineage of K060074, 1993–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FPA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FPA device

#1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 generations · no Class I recall
#2 Held for the reportin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K921899	Interlink System - T-Connector Extension Set Summary page 1 …travascular Administration Set (21 CFR 880.5440, Product Code FPA) Predicate Device(s): Baxter Interlink T-Connector Extension Set cleared under premarket notification K921899, cleared April 20, 1993. Device Description: The Interlink T-Connector Extension Set consists of an Interlink injection site in…	Baxter Healthcare Corp	1993	8

Also cleared against K921899: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K112799	Med-RX Extension Set with T-Connector	Benlan, Inc.	2011	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K112799 (Benlan, Inc., 2011) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K921899.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FPA

11in 2025

2007high 23 (2010) · low 4 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FPA

225in 2025

2007high 340 (2023) · low 75 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FPA

98in 2025

2007high 166 (2009) · low 1 (2021)2026

Class I (17 since 2007) Class II/III not classified

Adverse event reports per year · FPA

34,506in 2025

2007high 47,210 (2024) · low 1,499 (2007)2025

MAUDE reports naming product code FPA, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	16	75	17	1,499
2008	18	89	15	1,941
2009	10	166	166	2,512
2010	23	120	58	2,537
2011	12	87	28	4,407
2012	21	96	16 (4)	4,930
2013	13	90	64	4,651
2014	22	89	24	4,695
2015	17	123	6	6,625
2016	12	195	10	8,470
2017	17	240	13	6,462
2018	4	177	4	6,574
2019	7	161	13	11,227
2020	10	327	107	9,563
2021	13	186	1	10,414
2022	14	213	9 (5)	13,393
2023	14	340	12 (4)	10,916
2024	7	244	13 (1)	47,210
2025	11	225	98 (1)	34,506
2026	5	266	10 (2)	—

What is it indicated for?

For use in neonatal population only. To be used with an indwelling catheter for the administration or withdrawal of fluids. This device may aid in the prevention of needlestick injuries.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060074 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060074: Interlink System-T-Connector Extension Set, Model 2N3326.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060074

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026